Therapeutic Use Exemption: Gray and Grayer

Mark Heinicke is the Associate Editor of Road Race Management and is responsible for most of the statistical surveys that appear in the newsletter. Mark has followed the sport as a participant and a writer for over 40 years. With gimpy knees forcing him on to a bicycle in recent years, he observes running in a frequently more detached but analytical manner, which provides a fresh perspective for those of us who spend most of our waking hours in the trenches.

Does the Therapeutic Use Exemption (TUE) for competitive athletes enable legalized cheating, or is it just a complicated means to “level a playing field?”

It may depend on a specific situation, the drug in question, or whom you ask. Case in point is the furor that erupted last fall in the pro cycling community, when the mischievous Russian hackers “Fancy Bears” released records showing the use of the steroid triamcinolone by Sir Bradley Wiggins prior to his competing in the Tour de France in 2011 and 2012 (which he won), and the 2013 Tour of Italy. (The records were hacked via the World Anti-Doping Agency (WADA) database; WADA has been scrambling to improve its security ever since.)

In all three cases, Wiggins was granted a TUE for triamcinolone to treat asthma and hay fever.  Triamcinolone belongs to the group of glucocortisoids (a class of corticosteroids), all of which are on the WADA banned list.

Prominent members of the cycling community pounced on the news with opinions ranging from absolutist (no use of banned substances whatsoever), to calls for reevaluation of the rules by which TUEs are granted (one of those calls came from former Sky teammate and three-time Tour de France victor Chris Froome, himself the beneficiary of a TUE in the 2014 Tour de Romandie ). No one seemed willing to stand up for the TUE procedures as they now exist. For a report on the controversy last fall, check out the following link:

http://www.cyclingnews.com/news/uci-defends-tue-use-after-russians-hack-wiggins-froome-medical-records/

Black-and-White versus Shades of Gray

The absolutist position—call it the Black-and-White position—is the easiest to understand and simplest to implement. A banned substance is banned for a reason. The reason may be performance enhancement, ill health effects, or both. The reason should hold for all. Using a banned drug? You’re out. Asthma or no asthma. End of story.

On the face of it, the absolutist position is the best way to go. Why? The basis is as follows.

The counterargument is, that if the drug, in the judgment of medical experts, does no more than “level the playing field” by undoing the effect of a disease such as asthma, without conferring any other competitive advantage, then its use should be permitted for certain sufferers under special conditions.

Every TUE requires review by a panel of medical experts—minimally three doctors/scientists by the rules of the WADA. Each panel is chosen by the governing body of a particular sport: in pro cycling, the Union Cycliste International (UCI).  So we’re already into a gray area: the qualifications of the experts themselves, and the qualifications of who is choosing them.

This is not to say that anyone is operating in bad faith. But the ambiguities surrounding the qualifications of doctors in the panels, compounded by the incomplete understanding of how many of these drugs work, undermine the credibility of the process.

The language of the IAAF on this issue does not inspire confidence: the panel consists of  “at least three independent and experienced physicians with sound knowledge of clinical, sports, and exercise medicine.” Sound knowledge?  It is a purely qualitative judgment.  There’s no requirement that, for example, each physician show proof of having kept up with the latest developments in a rapidly changing field. Whoever chooses them may insist on it, or not, but there is no requirement under the rules.

The IAAF language mirrors that of the WADA “International Standard for TUE,” which you can find at https://www.wada-ama.org/sites/default/files/resources/files/WADA-2015-ISTUE-Final-EN.pdfat in section 5.2a.

As for the confusion as to how these drugs work, we need look no farther than the triamcinolone that was injected into Bradley Wiggins.

Doctors Weigh in on Triamcinolone: the Catabolic and the Anabolic

Interestingly, in the case of triamcinolone, three doctors in the field of respiratory illness, quoted by journalist Tom Cary in last September’s  Sport Cycling section of The Telegraph, all doubted that triamcinolone, could enhance performance. Furthermore, its side effects—such as cataracts, high blood pressure, diabetes, bone-thinning and Achilles tendon rupture—raised health risks that would make it a drug “of last resort” for the treatment of asthma. For details see: http://www.telegraph.co.uk/cycling/2016/09/20/sir-bradley-wigginss-last-resort-drug-was-utterly-bonkers-say-me/

Dr. Brian  Lipworth of the Scottish Centre for Respiratory Research, pointed out that triamcinolone is a catabolic steroid that breaks down muscle, as opposed to anabolic steroids that add muscle. He said there was “no scientific reason” why the drug would be performance-enhancing. Would it relieve asthma? Yes, but that’s only leveling the playing field for a player such as Sir Bradley Wiggins.

Lipworth brushed off anecdotal accounts of the performance-enhancing benefit of triamcinolone, such as the pronouncement of pro cyclist David Millar (banned for doping in 2004) that the drug was the most potent thing he took in his career. Said Lipworth,  “the fact that [Millar] was taking EPO and testosterone at the same time” meant that “the anabolic effect of the testosterone probably counteracted the triamcinolone.”

Incomplete Sports Medicine Knowledge

Probably counteracted? Dr. Lipworth is careful with his words. He is an expert on airway allergy and COPD, but he is not an expert on sport. For example: Glucorticoids (or corticosteroids) can bring about weight loss, and weight affects performance.  For pro cyclists faced with the immense climbs in the European grand tours, muscle mass imposes a weight penalty, and a catabolic steroid that breaks down muscle just might provide the lift to make you fly. The trade-off between gaining muscle and losing weight creates a delicate fine-tuning act for a pro cyclist in a stage race with big mountains.

Muscle mass aside, the reddest flag with triamcinolone, as well as other glucorticoids, is that it suppresses inflammation (in the case of asthma, inflammation of the airways). And minimizing inflammation is key to recovery from strenuous exercise. Who is to say that a drug that reduces inflammation to any degree is not a performance enhancer? Do we know that triamcinolone affects only the airways?

For a deeper shade of gray, you might look at the part of the IAAF rule that expands on what I quoted above: “The chairman of the IAAF TUESC may decide in appropriate circumstances to delegate responsibility for reviewing TUE applications to a single experienced physician.” (Emphasis mine.) When you add to the vagueness of “appropriate circumstances” the possibility that the decision could be in the hands of just one physician, you increase the potential for misjudgment.

(The language for the IAAF rule is taken from the “IAAF Medical and Anti-Doping Department Advisory Note – Therapeutic Use Exemptions, 2013” downloadable from the IAAF site as a .pdf. )

Numbers Game: the BADTUEC.

For a model of what a TUE Committee should look like, we might take a page from The Bahamas Anti-Doping Therapeutic Use Exemption Committee (BADTUEC). You can find it at http://www.bahamasadc.com/Therapuetic-Use-Committee.aspx

The BADTUEC has the least ambiguous language regarding a TUE committee that I could find through a web search. The committee should consist of six members, each of whom is appointed for at most three years (they can be reappointed). The exclusions cover such conflicts of interest as connection with an athlete or a sporting organization.

As specific as the rules are, there remain (at least) three questionable aspects of the BADTUEC. One, there are no specifications as to qualifications other than the term “duly qualified.” Second, there is nothing in the conflicts of interest clause that excludes members with interests in a pharmaceutical company. Third, the means by which the committee reaches a judgment is not specified. Unanimity could be a tough nut with six members. Majority rule leaves open the possibility of a 3-3 stalemate.  Could the committee chairman, appointed by the commission, have the final say, whatever the breakdown between the six members?

The deeper you look into the TUE process, the more fraught it is with ambiguity. It’s hard to avoid the inference that the principle of the TUE itself is flawed. It seeks to level a playing field which is already warped with the uncertainty and complexity of what individual drugs do, compounded by interactions with other drugs both legal and illegal. Moreover, the experts reviewing a case are not explicitly required, at least in the case of the IAAF, to show proof of current expert knowledge.

The most level playing field is where everyone follows the same rules, and prohibiting the use of banned drugs altogether gets it about as level as you could hope for.

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